Clinical Operations Lead

  • Full-time

Company Description

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

We’re looking for a knowledgeable, proactive, and result-oriented professional to join our management team and help lead and further develop our Clinical Operations team in Latin America region. You will lead and mentor a high-performing team while ensuring efficient resource utilization, operational excellence, and the successful delivery of clinical trials.  In this role, you will enjoy a broad range of operational and strategic management responsibilities, while contributing to the continued growth and success of the region.

The scope of responsibilities will include:

  • Line manage, coach, mentor, and develop Clinical Operations staff across multiple experience levels.
  • Supervises and conducts training of Monitors.
  • Mentors Monitors.
  • Plans and conducts supervised monitoring visits with training, authorization, and ongoing assessment purposes. 
  • Supports professional development of Monitors.
  • Contributes to the performance appraisal of Monitors. 
  • Supports Clinical Operations Managers with resource allocation and utilization of departmental staff.
  • Performs other Clinical Operations supervisory tasks. 

Qualifications

  • MD, PharmD, or a university degree in Life Sciences
  • Previous clinical research industry experience is required.
  • Previous experience working independently as an onsite Clinical Research Associate (CRA) is required (minimum of 4 years) 
  • Previous experience managing or mentoring clinical research professionals in a CRO, sponsor, or related clinical research environment.
  • Previous experience with Oncology or IBD is a plus.
  • Strong leadership, coaching, and employee development skills.
  • Experience with resource planning, workload management, and performance management.
  • Working knowledge of ICH-GCP, applicable regulatory requirements, and clinical trial operations.
  • Experience supporting audits, inspections, and quality initiatives is preferred.
  • Excellent communication, organizational, and problem-solving skills.
  • Proficiency with Microsoft Office applications and clinical research systems.
  • Advanced English proficiency (written and spoken).
  • Strong interpersonal skills with the ability to build trust, foster collaboration, and develop high-performing teams.

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

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